FDA approves Terumo trial for SFA stent

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Terumo Medical has received an investigational device exemption approval from the FDA for its OSPREY (Occlusive/Stenotic Peripheral Artery Revascularization) trial, which will evaluate the safety and effectiveness of the Misago Self-expanding Stent System for use in the superficial femoral artery. The trial will simultaneously enroll patients in the U.S. and Japan.

In the U.S., OSPREY is a single-arm, multicenter, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the Misago nitinol stent and 50 patients receiving percutaneous transluminal angioplasty.

The primary endpoints of the U.S. study are:

  • Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.
  • Freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.

The study will include up to 350 patients, a maximum of 250 patients in up to 30 centers in the U.S. and 100 patients in Japan. There have already been six patients enrolled in Japan, which received regulatory approval to begin the trial last year. The first U.S. enrollments are expected in June 2010. The U.S. principal investigator is J. Fritz Angle, MD, associate professor of radiology at the University of Virginia, Charlottesville.

"Peripheral vascular disease management continues to be a major clinical problem and we need better tools to improve revascularization of femoral-popliteal vessels," said Angle.

The stent is currently available for sale in Europe.

The OSPREY trial is part of the Medical Device Collaborative Consultation and Review of Premarketing Applications program, under the larger Harmonization by Doing initiative, a pilot project launched in December 2003 that seeks regulatory convergence between the FDA and MHLW-PMDA (Japan's regulatory bodies).

The learning obtained in the proof of concept trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for purposes of collecting better data, according to Terumo.